FDA Adverse Event
Injury
Summary report: N
SETROX S 53
MDR report key: 1073659
·
Received July 8, 2008
Report
- Report Number
- 1028232-2008-00716
- Event Type
- Injury
- Date Received
- July 8, 2008
- Date of Event
- April 22, 2008
- Report Date
- June 10, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO.
- Product Code
- DTB
- PMA / PMN Number
- P050037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUS MDR. THE DEVICE WAS NOT RETURNED FOR AN ANALYSIS. THUS, THE ANALYSIS IS BASED ON THE EXISTING PRODUCTION DOCUMENTS. THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE MANUFACTURING DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELEVANT TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. IN SUMMARY, THERE IS NO INDICATION OF A MANUFACTURING ERROR.
Description of Event or Problem · 1
OUS MDR. A DISLODGING OF THE RA LEAD WAS REPORTED. THE LEAD WAS REVISED. THE LEAD IS NOT AVAILABLE FOR ANALYSIS. IMPLANT AND EXPLANT DATES WERE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SETROX S 53 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO. | 350974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |